(88 days)
The SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. This mask is intended for single-patient reuse in the home and in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).
The SleepWeaver Anew Full Face Soft Cloth PAP Mask consists of a cloth cushion, headgear, and a 90° elbow swivel connector with anti-asphyxia valve.
The Circadiance LLC SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. It is for single-patient reuse in home and hospital/institutional environments for patients greater than 66 lbs (30 kg).
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Evaluation Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Evaluation | Materials suitable for intended use and patient contact | Biocompatibility requirements met, materials previously used or tested according to ISO 10993-1 and EDA G95-1. |
| Product Performance Testing | Device functions as intended for PAP therapy | Functioned as intended; results observed "as expected" for all tests (Physical Dead Space, Anti-Asphyxia Resistance, Anti-Asphyxia Operation, Pressure Drop, Carbon Dioxide Washout, Leak Rate). |
| Connector Performance | Connector functions as intended and safely | Functioned as intended; results observed "as expected". |
| Product Usability Evaluation | Device is usable by target population | Functioned as intended; results observed "as expected". |
| Biocompatibility | No adverse biological reactions | Biocompatibility requirements met. External surface of oral interface subject to Cytotoxicity, Sensitization, and Irritation testing. |
| Reliability | Device maintains performance over expected lifespan | Functioned as intended; results observed "as expected". |
| Packaging | Packaging protects the device and maintains sterility (if applicable) | Functioned as intended; results observed "as expected". |
| Accessory Interfacing | Device interfaces correctly with specified accessories | Functioned as intended; results observed "as expected". |
| Storage Testing | Device maintains integrity under specified storage conditions | Functioned as intended; results observed "as expected". |
| Labeling Review | Labeling is clear, accurate, and compliant | Functioned as intended; results observed "as expected". |
| Design Analysis | Design meets all functional and safety requirements | Functioned as intended; results observed "as expected". |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The performance data section lists various tests and evaluations, concluding with a general statement that "In all instances, the SleepWeaver Anew Full Face Soft Cloth PAP Mask functioned as intended and results of each test observed were as expected." This suggests the testing was likely internal validation rather than a clinical study with a large patient-based test set commonly associated with AI/software performance evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The device is a physical medical device (PAP mask), and its performance evaluation relates to physical and material properties, rather than diagnostic interpretation requiring expert-established ground truth like in AI algorithms.
4. Adjudication method for the test set:
Not applicable. The description of testing does not involve adjudication by multiple experts in the way an imaging diagnostic algorithm would. Performance was assessed through engineering and materials testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is a PAP mask, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is not an algorithm. Its function is to provide an interface for PAP therapy, which inherently involves human interaction (patient wearing the mask).
7. The type of ground truth used:
For the performance testing mentioned (e.g., Physical Dead Space, Anti-Asphyxia Resistance, Pressure Drop, Carbon Dioxide Washout, Leak Rate), the "ground truth" would be established by industry standards, engineering specifications, regulatory limits, and established scientific principles for the safe and effective operation of PAP masks. For biocompatibility, the ground truth is established by international standards like ISO 10993-1.
8. The sample size for the training set:
Not applicable. This device is a physical medical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).